Trial Outcomes & Findings for A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis (NCT NCT01119859)
NCT ID: NCT01119859
Last Updated: 2013-02-11
Results Overview
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and \> 2 years) and region (US and non-US).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
326 participants
Primary outcome timeframe
Baseline to Week 24
Results posted on
2013-02-11
Participant Flow
Participant milestones
| Measure |
Tocilizumab 8 mg/kg
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
163
|
|
Overall Study
COMPLETED
|
139
|
133
|
|
Overall Study
NOT COMPLETED
|
24
|
30
|
Reasons for withdrawal
| Measure |
Tocilizumab 8 mg/kg
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
10
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Insufficient therapeutic response
|
7
|
14
|
|
Overall Study
Refused treatment
|
3
|
6
|
|
Overall Study
Failure to return
|
3
|
0
|
Baseline Characteristics
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
Total
n=325 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.4 years
STANDARD_DEVIATION 12.95 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 12.43 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 12.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
262 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity \[symptom-free and no arthritis symptoms\], right end = maximum disease activity \[maximum arthritis disease activity\]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement. The analysis was adjusted for stratification factors of duration of RA (≤ 2 years and \> 2 years) and region (US and non-US).
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28)
|
-3.3 Units on a scale
Interval -3.57 to -3.02
|
-1.8 Units on a scale
Interval -2.1 to -1.55
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.
The percentage of patients who achieved remission of their rheumatic arthritis at Week 24, as measured by a DAS28 score \< 2.6, is reported.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Percentage of Patients With a Remission Response (Disease Activity Score 28 [DAS28] < 2.6) at Week 24
|
39.9 Percentage of patients
|
10.5 Percentage of patients
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.
The percentage of patients who had low rheumatic arthritis disease activity at Week 24, as measured by a DAS28 score of 3.2 or less, is reported.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Percentage of Patients With Low Disease Activity (Disease Activity Score 28 [DAS28] ≤ 3.2) at Week 24
|
51.5 Percentage of patients
|
19.8 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.
Improvement must be seen in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line "no disease activity" \[symptom-free and no arthritis symptoms\] and the extreme right end "maximum disease activity"; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line "no pain" and the extreme right end "unbearable pain"); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
ACR 20 response
|
65.0 Percentage of patients
|
49.4 Percentage of patients
|
|
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
ACR 50 response
|
47.2 Percentage of patients
|
27.8 Percentage of patients
|
|
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline at Week 24
ACR 70 response
|
32.5 Percentage of patients
|
17.9 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Percentage of Patients With a European League Against Rheumatism (EULAR) Good Response at Week 24
|
51.5 Percentage of patients
|
19.8 Percentage of patients
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 efficacy assessment.
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=163 Participants
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 Participants
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Percentage of Patients With a European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24
|
77.9 Percentage of patients
|
54.9 Percentage of patients
|
Adverse Events
Tocilizumab 8 mg/kg
Serious events: 19 serious events
Other events: 66 other events
Deaths: 0 deaths
Adalimumab 40 mg
Serious events: 16 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab 8 mg/kg
n=162 participants at risk
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 participants at risk
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
1.2%
2/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Appendicitis perforated
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Haematoma infection
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Infective tenosynovitis
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Parotitis
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Postoperative abscess
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Vestibular neuronitis
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Cardiac disorders
Myocardial infarction
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
1.2%
2/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
1.9%
3/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
General disorders
Malaise
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
General disorders
Sudden death
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
1/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
0.00%
0/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
Other adverse events
| Measure |
Tocilizumab 8 mg/kg
n=162 participants at risk
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
|
Adalimumab 40 mg
n=162 participants at risk
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
18/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
10.5%
17/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
17/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
8.0%
13/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
9/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
6.8%
11/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.6%
9/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
9.3%
15/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Vascular disorders
Hypertension
|
8.0%
13/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
4.3%
7/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Nervous system disorders
Headache
|
5.6%
9/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
5.6%
9/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
6/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
6.2%
10/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
4/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
5.6%
9/162 • Adverse events were recorded for each patient from Baseline until 12 weeks after the last infusion of a study treatment.
Safety population: All patients who received at least 1 dose of tocilizumab or adalimumab and had at least 1 post-treatment safety assessment.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER